Tonix Pharmaceuticals Announces First Patient Dosed in the Investigator-Initiated FOCUS Study of Tonix’s Intranasal Potentiated Oxytocin in AVP-D Conducted by Massachusetts General Hospital

Core Insights - Tonix Pharmaceuticals is conducting a pilot study named FOCUS to evaluate its investigational intranasal potentiated oxytocin products in patients with Arginine-Vasopressin Deficiency (AVP-D), a rare endocrine disorder linked to oxytocin deficiency and mental health issues [1][2] Group 1: Study Overview - The FOCUS study is a randomized, double-blind, placebo-controlled crossover trial aimed at generating preliminary data for future clinical studies on oxytocin replacement therapy in AVP-D [1][2] - The study will assess the effects of two different doses of investigational intranasal oxytocin products (6 IU, TNX-2900 and 24 IU, TNX-1900) on anxiety, depression, and socioemotional functioning in patients with AVP-D [2] Group 2: Product Information - TNX-1900 and TNX-2900 are based on Tonix's patented intranasal magnesium-potentiated oxytocin formulations, designed to enhance oxytocin receptor binding and its effects on trigeminal neurons [3] - TNX-1900 is being developed for chronic migraine prevention, while TNX-2900 targets Prader-Willi syndrome in children and adolescents [3] Group 3: Company Background - Tonix Pharmaceuticals is a fully integrated biotechnology company with a focus on central nervous system disorders, immunology, and rare diseases, among other areas [10] - The company has received FDA approval for Tonmya™, a non-opioid analgesic for fibromyalgia, marking the first new prescription medicine approval for this condition in over 15 years [10]